Intravenous immunoglobulins: evolution of commercial IVIG preparations.
Since its first use in 1952, human immunoglobulin has been used to treat people who have inherited antibody deficiencies. This article summarizes IVIG clinical development in primary immunodeficient patients and manufacturing improvements introduced over time. Manufacturing improvements include purification procedures that have reduced the incidence of adverse events and improved clinical efficacy, as well as virus inactivation and removal steps that have increased safety from blood-borne infections. Current manufacturing procedures, IVIG production trends, and recent clinical trial results are also reviewed.
Hooper
John A
JA
BioCatalyst Research LLC, 217 Camelot Drive, Liberty, MO 64068, USA. johnhooper@kc.rr.com
D000818:Animals; D001424:Bacterial Infections / Q000628:therapy; D002648:Child; D002986:Clinical Trials as Topic; D003257:Consumer Product Safety; D004340:Drug Contamination; D004345:Drug Industry; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects / Q000737:chemistry / Q000302:isolation & purification / Q000627:therapeutic use; D007153:Immunologic Deficiency Syndromes / Q000139:chemically induced / Q000188:drug therapy; D007223:Infant; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000139:chemically induced / Q000188:drug therapy; D007262:Infusions, Intravenous; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000737:chemistry; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000139:chemically induced / Q000188:drug therapy; D014777:Virus Diseases / Q000276:immunology / Q000517:prevention & control / Q000635:transmission; D038301:Virus Inactivation
D016756:Immunoglobulins, Intravenous; D004364:Pharmaceutical Preparations